Registration Dossier
Registration Dossier
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EC number: 603-006-7 | CAS number: 124728-62-7
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.64 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 75
- Dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 123 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Default (DNEL calculator)
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL calculator)
- AF for differences in duration of exposure:
- 6
- Justification:
- Default (DNEL calculator)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default (DNEL calculator)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL calculator)
- AF for intraspecies differences:
- 5
- Justification:
- Default (DNEL calculator)
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL calculator)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- irritation (respiratory tract)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.467 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 300
- Dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 140 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Default (DNEL calculator)
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL calculator)
- AF for differences in duration of exposure:
- 6
- Justification:
- Default (DNEL calculator)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (DNEL calculator)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL calculator)
- AF for intraspecies differences:
- 5
- Justification:
- Default (DNEL calculator)
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL calculator)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
Considering the Guidance on information requirements and chemical safety assessment, R.8 Characterisation of dose [concentration]-response for human health (May 2008) DNEL acute and DNEL long-term might be relevant for the chemical safety assessment.
Acute, systemic DNELs
The test item is not classified for acute systemic toxicity according to Regulation (EC) No 1272/2008 based on the available study results after oral exposure. The test item is not classified for acute systemic toxicity after dermal exposure according to Regulation (EC) No 1272/2008 based on the category approach of LC compounds.
Acute systemic effects via inhalation can be excluded as no exposure via inhalation is assumed based on the physico-chemical profile of the test item (particle size > 100 µm, low vapour pressure 3.9E-6 Pa at 25 °C).
Acute/long term DNELs for local effects
Skin irritation/corrosion: The test item is not classified for skin irritation/corrosion according to Regulation (EC) No 1272/2008. Therefore, no hazard was identified.
Eye irritation: The test item is not classified for eye irritation/corrosion according to Regulation (EC) No 1272/2008. Therefore, no hazard was identified.
Skin sensitization: The test item is not classified for skin sensitization according to Regulation (EC) No 1272/2008. Therefore, no hazard was identified.
Respiratory irritation: No experimental data on respiratory irritation are available. According to ECHA Guidance Doc R.7a, the term "respiratory tract irritation" is often used to indicate either or both of two different toxicological effects. These are i) cytotoxic effects in the affected tissue, and ii) sensory irritation. Cytotoxic effects in the respiratory tract are comparable to dermal and eye irritation. "Sensory irritation" refers to the local and central reflex interaction of a substance with the autonomic nerve receptors, which are widely distributed in the mucosal tissues of the eyes and upper respiratory tract.
Since the test item is neither classified for skin irritation nor for eye irritation according to Regulation (EC) No 1272/2008, no respiratory irritation is to be expected.
Long term systemic DNEL - inhalation
a) Relevant dose descriptor - starting point
A Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test rats according to OECD 422 Guideline is available. Rats were exposed to the test item via oral route 7days per week. The NOAEL was determined to be 100 mg/kg bw/d.
b) Modification of starting point
Since no experimental data on the relevant route of exposure are available, route-to-route extrapolation (oral to inhalative) has to be conducted taking into account the follwing paramters:
Standard respiratory volume rat (sRVrat) for 8 hours: 0.38 m3/kg bw/d
Standard respiratory volume of humans (sRVhumans) for 8 hours: 6.7 m3
Standard respiratory volume of workers (wRV) with light physical activity for 8 hours: 10 m3
Exposure conditions (rat): 7 days per week
Exposure conditions (worker): 5 days per week
Furthermore, a factor of 2 is applied for the potential higher bioavailability via inhalation compared to oral route (ABSoral-rat/ABSinhal-human = 50%/100% = 0.5) according to Guidance on information requirements and chemical safety assessment, chapter R.8.
Corrected NOAEC (inhal) for workers = 100 mg/kg bw/d * (1/0.38 m3/kg bw/d) * (6.7 m3/10 m3) * 0.5 * (7 d/5 d) = 123 mg/m3.
c) Assessment factors: 75
Duration of exposure: 6 (default)
Interspecies differences (allometric): 1 (default)
Other interspecies differences: 2.5 (default)
Intraspecies differences: 5 (default)
By applying an assessment factor of 75, the inhalatory DNEL for workers is considered to be 1.64 mg/m3.
Long term systemic DNEL - dermal
a) Relevant dose descriptor - starting point
A Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test rats according to OECD 422 Guideline is available. Rats were exposed to the test item via oral route 7days per week. The NOAEL was determined to be 100 mg/kg bw/d.
b) Modification of starting point
Since no experimental data on the relevant route of exposure are available, route-to-route extrapolation (oral to dermal) has to be conducted taking into account the follwing paramters:
Exposure conditions (rat): 7 days per week
Exposure conditions (worker): 5 days per week
For oral-to-dermal extapolation a default factor of 1 (ABSoral-rat/ABSdermal-human) was used as in general dermal absorption will not be higher than oral absorption (Guidance on information requirements and chemical safety assessment, chapter R.8).
Corrected NOAEL (dermal) for workers = 100 mg/kg bw/d * 1 * (7 d/5 d) = 140 mg/kg bw/d
c) Assessment factors: 300
Duration of exposure: 6 (default)
Interspecies differences (allometric): 4 (default)
Other interspecies differences: 2.5 (default)
Intraspecies differences: 5 (default)
By applying an assessment factor of 300, the DNEL (dermal) for workers is considered to be 0.47 mg/kg bw/d.
References
1) Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.7a: Endpoint specific guidance, Version 6.0, July 2017, ECHA-17 -G-18 -EN
2) Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of dose [concentration]-response for human health, Version 2.1, Nov 2012, ECHA-2010 -G-19 -EN
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Additional information - General Population
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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